Evaluation of informed consent: a pilot study

Länsimies-Antikainen, Helena; Pietilä, Anna‐Maija; Laitinen, Tomi; Schwab, Ursula; Rauramaa, Rainer; Länsimies, Esko

doi:10.1111/j.1365-2648.2007.04279.x

Cited by 14 publications

(20 citation statements)

References 24 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…First, among respondents, our finding that a personal connection to breast cancer served as a principal driver to decision-making to enroll in the MMHS corresponds well with the literature showing that family cancer history (22) and illness of a friend or relative (23) can serve as motivation for participation in medical research. In the epidemiology literature, a personal connection to breast cancer is reported as a strong motivator for participation in research, as women who participated in a breast cancer prevention trial were observed to be “keenly aware of their responsibility to others” and stated that they took part in hopes of preventing breast cancer in future generations (24).…”

Section: Discussionsupporting

confidence: 80%

“…Investigators are now challenged to comply with the HIPAA regulations and wording and balance those requirements with the need to relay the study purpose in a way that a layperson can truly understand. As with other studies (23), focus group participants reported confusion after reading the consent form and this did serve as a barrier to participation or at least gave cause for concern. Some focus groups participants asked that a paragraph explaining the study purpose and the basic concepts presented in the consent form be summarized on the front of the consent in layman's terms, which was provided by the study investigators (see materials).…”

Section: Discussionsupporting

confidence: 51%

See 1 more Smart Citation

Healthy Women's Motivators and Barriers to Participation in a Breast Cancer Cohort Study: A Qualitative Study

Sinicrope

Patten

Bonnema³

et al. 2009

Annals of Epidemiology

View full text Add to dashboard Cite

Background This focus group study describes motivators and barriers to participation in the Mayo Mammography Health Study (MMHS), a large-scale longitudinal study examining the causal association of breast density with breast cancer, involving completion of a survey, providing access to a residual blood sample for genetic analyses, and sharing their results from a screening mammogram. These women would then be followed long-term for breast cancer incidence and mortality. Methods 48 Women participated in six focus groups, four with MMHS non-respondents (N=27), and two with MMHS respondents (N=21). Major themes were summarized using content analysis. Social Cognitive Theory (SCT) was used as a framework for interpretation of the findings. Results Barriers to participation among MMHS non-respondents were: 1) lack of confidence in their ability to fill out the survey accurately (self-efficacy); 2) lack of perceived personal connection to the study or value of participation (expectancies); and 3) fear related to some questions about perceived cancer risk and worry/concern (emotional coping responses). Among MMHS respondents, personal experience with cancer was reported as a primary motivator for participation (expectancies). Conclusions Application of a theoretical model such as SCT to the development of a study recruitment plan could be used to improve rates of study participation and provide a reproducible and evolvable strategy.

show abstract

Section: Discussionsupporting

confidence: 80%

Section: Discussionsupporting

confidence: 51%

Healthy Women's Motivators and Barriers to Participation in a Breast Cancer Cohort Study: A Qualitative Study

Sinicrope

Patten

Bonnema³

et al. 2009

Annals of Epidemiology

View full text Add to dashboard Cite

show abstract

“…The questionnaire was self-administered and tested in a pilot study [9]. The key elements of informed consent were defined as follows: information, understanding, competence, voluntariness, and decision-making.…”

Section: Methodsmentioning

confidence: 99%

Is informed consent related to success in exercise and diet intervention as evaluated at 12 months? DR's EXTRA study

et al. 2010

Self Cite

View full text Add to dashboard Cite

BackgroundThere is a permanent need to evaluate and develop the ethical quality of scientific research and to widen knowledge about the effects of ethical issues. Therefore we evaluated whether informed consent is related to implementation and success in a lifestyle intervention study with older research participants. There is little empirical research into this topic.MethodsThe subjects (n = 597) are a subgroup of a random population sample of 1410 men and women aged 57-78 years who are participating in a 4-year randomized controlled intervention trial on the effects of physical exercise and diet on atherosclerosis, endothelial function and cognition. Data were collected in two steps: A questionnaire about informed consent was given to all willing participants (n = 1324) three months after the randomization. Data on implementation and success in the exercise and diet interventions were evaluated at 12 months by intervention-group personnel. The main purpose of the analysis procedure performed in this study was to identify and examine potential correlates for the chosen dependent variables and to generate future hypotheses for testing and confirming the independent determinants for implementation and success. The nature of the analysis protocol is exploratory at this stage.ResultsAbout half of the participants (54%) had achieved good results in the intervention. Nearly half of the participants (47%) had added to or improved their own activity in some sector of exercise or diet. Significant associations were found between performance in the interventions and participants' knowledge of the purpose of the study (p < 0.001), and between success in interventions and working status (p = 0.02), and the participants' knowledge of the purpose of the study (p = 0.04).ConclusionThe main finding of this study was that those participants who were most aware or had understood the purpose of the study at an early stage had also attained better results at their 12-month intervention evaluation. Therefore, implementation and success in intervention is related to whether subjects receive a sufficient amount and are able to comprehend the information provided i.e. the core principles of informed consent.Trial Registration(ISRCTN 45977199)

show abstract

“…The main function of RECs in the UK is to ensure that safeguards are in place to protect research participants from harm (Schüklenk 2000, WMA 2000, DoH 2005, SEHD 2006), a function which is based primarily on the principle of non‐maleficence. Informed consent by research participants is the pre‐condition incorporated in a range of international guidelines for any ethical research which exists to protect them from harm whilst respecting their autonomy (Doyal 1997, Schüklenk 2000, WMA 2000, Länsimies‐Antikainen et al. 2007).…”

Section: Ethical Tensionsmentioning

confidence: 99%

How ethical is ethical research? Recruiting marginalized, vulnerable groups into health services research

Smith

2008

Journal of Advanced Nursing

View full text Add to dashboard Cite

show abstract

Evaluation of informed consent: a pilot study

Abstract: This study strengthened the perception that more extensive research about research participants is needed.

Cited by 14 publications

References 24 publications

Healthy Women's Motivators and Barriers to Participation in a Breast Cancer Cohort Study: A Qualitative Study

Healthy Women's Motivators and Barriers to Participation in a Breast Cancer Cohort Study: A Qualitative Study

Is informed consent related to success in exercise and diet intervention as evaluated at 12 months? DR's EXTRA study

How ethical is ethical research? Recruiting marginalized, vulnerable groups into health services research

Contact Info

Product

Resources

About